Merck & Schering-Plough’s Long Reply to Vytorin Questions

Merck & Schering-Plough drop a stem-winder of a press release this morning to announce to the world that they “strongly object to mischaracterizations” about the Enhance trial of their cholesterol drug Vytorin.

The companies have been accused of stalling in releasing the results, which suggest that Vytorin doesn’t slow the progression of heart disease any better than a generic statin, and Congress has taken a strong interest.

“While the ENHANCE trial was time consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial,” a top Schering researcher says in the statement. The statement also notes that Vytorin “has not been shown to reduce heart attacks or strokes more than simvastatin alone.”

And — perhaps in response to allegations that company executives sold stock after the trial was completed but before the data were released — the statement says that until December 31, 2007, “neither the patients nor the researchers nor the companies knew the group of patients that received each therapy” and therefore didn’t know the results of the trial.

The statement also includes a long, long timeline of the study, which started enrolling patients in 2002 and the results of which were scheduled to be presented in 2006. A sign that things weren’t going as planned emerged in 2005, when reviewers observed “results that appear biologically implausible,” the statement says. (The study relied on a reading of the thickness of the carotid artery called IMT, which we discussed at length in an earlier post.)

So they changed the way they were reading the images — but in December of 2006, they found that “data quality problems still exist.” They found “significant fluctuations in IMT (in individual patients) within short periods of time and over time, which would not be expected to occur in nature. There was also missing data.

But a report the next month from an independent consultant found that the data quality was “similar to that in other IMT trials,” according to the timeline. Nevertheless, the researchers spent the rest of 2007 trying to get the (still-blinded) data into shape, according to the statement.

Finally, the results were announced via press release earlier this month, and are expected to be presented more fully at a conference in March.

Comments (5 of 25)

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DebbieSeptember 14, 2011, 03:26
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Comments
Trevor: September 30, 2011, 22:08

Integrated: October 14, 2011, 03:47

8:42 pm February 6, 2008

Sandra wrote :

YJ you have to be very poorly educated. If you do not like the way things are done in America, then you should just move to a third world country and get your fresh vegetables and poor healthcare. As another poster said above, "Capitalism is the fuel for innovation". Why dont we just regulate Big Pharma even more and let you decide which drugs are developed. Do you live in a cave or something? Better yet, when your doctors prescribe medications for you make sure that you tell them that you are opposed to that.

7:27 pm January 30, 2008

YJ wrote :

A lot of "dis"eases could be squashed, if Big Pharma was shut down. Many times, it's their drugs that cause these "dis"eases. Why would I take a drug that's supposed to ease gastroenteritis, when the drug, itself, causes elevated blood pressure, ulcers, irregular heartbeat, nausea, coma and maybe even death? I'd rather stick with that stomach ache, bloating, whatever that was probably caused by ingesting the chemicals these Big Pharma have sold to food companies who then add them to our food supply. It all comes full circle, when you really get into the dirty dealing going on between these companies. Why do you think the FDA handles food and drugs? It's all the same thing. The average food bought from the store contains more chemicals than food and its resulting nutritional value, but if you stand to make money when Big Pharma makes money you would never admit to this. Instead you pump fear into unsuspecting folks leading them to believe that this country is better off because of these synthetic chemicals, when, really, these synthetic chemicals have a lot to do with the current state of health in America. I can't hardly think of any "ailment" that Big Pharma hasn't whipped up a so-called cure for. Afterwhile, we'll be taking our daily meals in pill form. It's not far off. Sheesh!

12:04 pm January 30, 2008

Dick G wrote :

Bill,
An LDL-C of 60 is normally achievable only through artificial means. Are our genetics so flawed that most of us are unable to maintain healthy lipid levels while eating a healthy diet? Or have we been misled to believe that cholesterol levels that were unheard of a few years ago are heart protective? Also, if your taking Vytorin the Ezetimibe in it could also be blocking the absorption of nutrients that are essential to cardiovascular health.

10:39 am January 30, 2008

william sheehan wrote :

Unrealistic to expect an externally held ultrasound transducer to detect meaningful sub millimeter measurement changes in assessing the carotid artery intima. Unlikely that an oral medication could act like a "rotorooter' in removing the chronic intimal changes! Endovascular ultrasound (too invasive for patient management etc ) far more accurate. Personally, my experience taking Vytorin has been dramatic, after being on Zoccor for years, my LDL dropped from 100 to 60 with NO adverse effects . ( I do NOT own stock in either company)